1. Field of the Invention
The present invention relates to a device capable of initiating and enhancing urine flow from a bladder. Specifically, the invention is a therapeutic device that communicates thermal energy to the groin and penis in a non-invasive fashion, so as to enable vasodilation and neurological stimulation of the urinary track and to relax muscles in the surrounding tissue and bladder neck. The invention is contoured and conformal, thereby maximizing contact with the groin and transfer of heat thereto.
2. Description of the Related Art
Bladder and urinary tract dysfunctions are common among males over the age of forty. Dysfunction may be caused by several prostate-related medical conditions, including Benign Prostatic Hyperplasia, commonly referred to as BPH, Prostatitis, and Prostate Cancer. Benign Prostatic Hypertrohpy is defined as a benign, otherwise non-cancerous, adenomatous hyperplasia of the paraurethral prostate gland. Prostatitis is an inflammation of the prostate gland, usually due to an infection. Prostate cancer, as the name suggests, is a malignant growth involving the prostate.
As shown in FIG. 1, the prostate 1 is a doughnut-shaped gland with two lobes located at the bottom of the bladder 4 between the rectum 2 and base of the penis 3, adjacent to the scrotum 6. The prostate 1 encircles the urethra 5, the latter facilitating flow of urine from the bladder 4 out through the penis 3. An enlargement of the prostate 1 causes narrowing of the urethra 5, thereby diminishing urine flow in part or whole.
Symptoms of an enlarged prostate might include difficulty initiating urination, weak urine stream, persistent urge to urinate, and frequent nocturnal urination. In severe cases, obstruction of urine flow may lead to complications, including complete blockage of the urethra, urinary tract infections, stones in the bladder, and blood in the urine. It is estimated that at least seventy percent of men have noticeable enlargement of the prostate by the age of 70.
A variety of treatments, including medications and surgical procedures, are presently known to address the causes and/or symptoms of an enlarged prostate.
Medications are intended to control the growth of and in some cases shrink the prostate. For example, Finasteride limits the production of dihydrotestosterone (DHT), the hormone believed to control prostate growth. Side effects include reduced sex drive, erectile dysfunction, and decreased sperm count. In another example, alpha blockers relax the muscles of the bladder neck and prostate, producing a slight increase in urinary flow. Side effects include headaches, dizziness, light headedness, low blood pressure, fatigue and a sense of difficulty in breathing.
Medical procedures include transurethral resection of the prostate (TURP), transurethral incision of the prostate (TUIP), transurethral ultrasound guided laser incision of the prostate (TULIP), interstitial laser coagulation (ILC), transurethral vaporization of the prostate (TUVP), prostatic stent implantation, open prostatectomy, transurethral microwave thermotherapy (TUMT), Targis™, transurethral needle ablation of the prostate (TUNA), and water induced thermotherapy (WIT).
TURP is a procedure requiring anesthesia but no external incision. A resectoscope, having a light, valves to control irrigation fluid, and an electrical loop to cut then seal blood vessels, is inserted into the penis through the urethra. The loop is used to remove prostate tissue in pieces, which are then carried into the bladder via irrigating fluids, and flushed out after the procedure.
TUIP widens the urethra by making several small cuts along the neck of the bladder and prostate. This procedure reduces pressure applied by the prostate onto the urethra, thereby making urination easier. TULIP is identical to TUIP, except that cuts are made with a laser.
ILC requires the insertion of a cystoscope into the urethra to introduce a special fiberoptic probe directly into the prostate. The probe focuses a beam of low-power laser energy to vaporize prostate tissue so as to shrink the prostate.
TUVP is a transurethral procedure, which employs a grooved roller bar to directly apply heat to the prostate so as to vaporize tissue therein.
A prostatic stent implant is a tiny, spring-like device inserted into the urethra. When expanded, the stent widens the urethra to permit increased flow of urine. Prostatic stents are preferred for patients who have other medical problems that prohibit medication and surgery.
Open prostatectomy is preferred when the prostate is greatly enlarged, the bladder has been damaged, or the patient has other complications prohibiting transurethral surgery. The patient is anesthetized and an external incision is made either in the lower abdomen or in the perineum. Thereafter, prostate tissue is removed from inside the gland.
TUMT employs a catheter having an antenna at one end to deliver heat via microwave energy to the prostate in a targeted fashion. Deep heating of the prostate improves urine flow via a reduction in the size of the prostate. A fiberoptic thermo-sensor monitors temperature throughout the procedure and a cooling system circulates water within the catheter to protect the urinary tract.
Targis™ is an advanced form of microwave therapy, including a flexible catheter inserted into the urethra, for the targeted delivery of energy to destroy tissue in the prostate. A balloon at the end of the catheter is inflated to position the microwave antenna within the prostate. Chilled water is circulated through the catheter to shield healthy urethral tissue from thermal effects.
TUNA delivers low level radio frequency (RF) energy onto the prostate via two small probes inserted through the urethra. RF energy heats and shrinks the prostate, thereby relieving the obstruction while avoiding damage to the urethra and surrounding tissue.
WIT heats the prostate via a treatment balloon filled with heated water. The treatment balloon, resting in the prostatic urethra, inflates and then fills with water. Temperature controlled water then circulates through the insulated shaft into the treatment balloon. The catheter conducts heat through the insulated shaft to the prostate gland, raises the temperature of the gland, and then destroys the obstructive tissue.
The procedures described above are invasive in that one or more medical instruments are inserted into the body so as to heat, destroy, and/or remove tissue comprising the prostate. Furthermore, each procedure suffers from at least one post-procedure complication, including pain, frequent urination, swelling, bleeding, infection, sexual dysfunction, and prolonged recovery time.
The side effects of medications and complications associated with surgical procedures far outweigh the benefits to most males with prostate-related bladder and urinary tract dysfunction.
As such, what is sorely required is a therapeutic device to relieve the symptoms of prostate related urinary dysfunction while avoiding the side effects and complications of the related arts.